I've had three distinct careers: biomedical scientist; FDA drug regulator; and scholar at the Hoover Institution, a think-tank at Stanford University. During the first of these, I worked on various aspects of gene expression and regulation in viruses and mammalian cells. I was the co-discoverer of a critical enzyme in the influenza (flu) virus. While at the FDA, I was the medical reviewer for the first genetically engineered drugs and thus instrumental in the rapid licensing of human insulin and human growth hormone. Thereafter, I was a special assistant to the FDA commissioner and the founding director of the FDA's Office of Biotechnology. Since coming to the Hoover Institution, I have become well known for both contributions to peer-reviewed scholarly journals and for articles and books that make science, medicine, and technology accessible to non-experts. I have written four books and about 2,000 articles. I appear regularly on various nationally syndicated radio programs. My most frequent topics include genetic engineering, pharmaceutical development, and the debunking of various manifestions of junk science.

2/22/2012 @ 2:23PM7,110 views

The Science of Things That Aren't So

Chemistry Nobel Laureate Irving Langmuir related in a landmark 1953 speech his visit to the laboratory of J.B. Rhine at Duke University, where Rhine was claiming results of ESP experiments that could not be predicted by chance, and which he ascribed to psychic phenomena. Langmuir discovered that Rhine was only selectively counting the data in his experiments, omitting the results from those he believed were guessing in order to humiliate him.

The evidence? Rhine felt that some of the scores were too low to have occurred by chance, and that it would, therefore, actually be misleading to include them.

Langmuir dubbed this deviation from the principles of the scientific method “pathological science,” the “science of things that aren’t so.”

Virtually all scientists would agree that Rhine’s methodology crosses the line of incompetence and sloppiness and falls into the category of scientific misconduct, but that line is blurred today by some scientists whose research reflects an obvious political agenda. Often, that agenda is intractable opposition to and obstruction of whatever research, product or technology they happen to dislike.

A current example of a scientist who is less guilty of actually fudging data to get the desired answer than of performing poorly designed experiments and grossly misrepresenting the results is the French biologist Gilles-Eric Séralini, who has made a specialty of poorly designed, irrelevant, uninterpretable (but over-interpreted) experiments intended to demonstrate harm from genetically engineered (also known as “genetically modified,” or GM) plants in various highly contrived scenarios.

His latest exercise in science-for-propaganda is an article that purports to show toxic effects of two toxins from a bacterium called Bacillus thuringiensis (Bt), that have been introduced into many varieties of corn, soybean and cotton to enhance insect-resistance. (It is noteworthy that spores and purified proteins produced by Bt have been used to control insect pests since the 1920s; considered safe except to susceptible insects, various strains and formulations of Bt are readily available to home gardeners.) Séralini and his collaborators examined the effects of two Bt toxins (in the presence and absence of the herbicide Roundup) in vitro on a line of cultured embryonic kidney cells. They looked for – and found — effects on three biomarkers of “cell death” – namely, changes in the levels of several enzymes.

There are a number of fundamental flaws in Séralini’s experiment.

First, because testing in a petri dish is poorly predictive of effects on an intact animal in the real world, it is not a substitute for testing in whole animals. Many chemicals and proteins that we consume routinely and uneventfully would be toxic if applied directly to naked cells. So that absorption and distribution in the body are taken into account, toxicological testing should be performed in a way that resembles the anticipated exposure(s) of the intact organism in the real world.

Second, almost every chemical tested is toxic to isolated, naked, literally defenseless cells in petri dishes. An elevated concentration of table salt, for example, causes plated cells to wither and die; many are likewise sensitive to small changes in pH. This situation is very different from an intact, living organism: Animals have evolved elaborate defenses against the millions of chemicals present in the environment that can harm cells. The first line of defense is as simple as their skin, and the cells that line the gastrointestinal tract constitute a similar barrier. Bt proteins cannot penetrate those cells, so other cells and organs in intact animals are not exposed to Bt proteins. This fact — which Séralini conveniently ignores — has been known for decades.

Third, Séralini and his fellow travelers ignore the ancient adage that the dose makes the makes the poison. It has been known since Paracelsus made the observation in the 16th century that all things can be poisonous but the dose determines whether or not they are harmful. Without expressing it in those terms, we all know it to be true for substances as disparate as carbon monoxide and Tylenol.

Séralini’s claim that in his experiments the cultured cells were exposed to agriculturally relevant doses of Roundup, a brand name of the ubiquitous herbicide glyphosate, is disingenuous. The food products produced from widely cultivated, herbicide–tolerant, genetically engineered soybeans and corn contain only minute amounts of Roundup that are several orders of magnitude lower than those used by Séralini in his experiments. Roundup itself is about as toxic as baking soda. Parenthetically, it is interesting to note that Bt protein actually protected exposed cells from damage by Roundup. But of course in the real world isolated cells would never be exposed to either substance.

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